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Establishment of a Prospective Cohort of Mechanically Ventilated Patients Open Access Protocol BMJ Open: first published as 10.1136/bmjopen-2014-005803 on 16 January 2015. Downloaded from Establishment of a prospective cohort of mechanically ventilated patients in five intensive care units in Lima, Peru: protocol and organisational characteristics of participating centres Joshua A Denney,1 Francesca Capanni,1 Phabiola Herrera,1 Augusto Dulanto,2 Rollin Roldan,3 Enrique Paz,4 Amador A Jaymez,5 Eduardo E Chirinos,6 Jose Portugal,3 Rocio Quispe,3 Roy G Brower,1 William Checkley,1,7 INTENSIVOS Cohort Study To cite: Denney JA, ABSTRACT INTRODUCTION et al Capanni F, Herrera P, . Introduction: Mechanical ventilation is a cornerstone Mechanical ventilation has become a main- Establishment of a in the management of critically ill patients worldwide; stay of therapy in the care of critically ill prospective cohort however, less is known about the clinical management of mechanically ventilated patients. Intensive care unit (ICU) practices, of mechanically ventilated patients in low and middle patients in five intensive care mechanical ventilation strategies and their income countries where limitation of resources units in Lima, Peru: protocol social costs in high-income countries (HIC) and organisational including equipment, staff and access to medical information may play an important role in defining are well documented. For example, in characteristics of participating fi 1 centres. BMJ Open 2015;5: patient-centred outcomes. We present the design of a Germany, Chal n calculated that ICU care e005803. doi:10.1136/ prospective, longitudinal study of mechanically comprised 20% of hospital costs. In the USA, 2 bmjopen-2014-005803 ventilated patients in Peru that aims to describe a large Wunsch et al projected that 3% of inpatient cohort of mechanically ventilated patients and identify hospitalisations required mechanical ventila- ▸ Prepublication history for practices that, if modified, could result in improved tion in 2005, comprising 30% of all ICU this paper is available online. patient-centred outcomes and lower costs. admissions and accounting for a dispropor- To view these files please Methods and analysis: Five Peruvian intensive care tionate 12% of all hospital costs. Factors con- http://bmjopen.bmj.com/ visit the journal online units (ICUs) and the Medical ICU at the Johns Hopkins tributing to a higher cost of an individual (http://dx.doi.org/10.1136/ Hospital were selected for this study. Eligible patients bmjopen-2014-005803). ICU stay include sepsis and initiation of were those who underwent at least 24 h of invasive mechanical ventilation.34Despite the higher mechanical ventilation within the first 48 h of Received 29 May 2014 cost and quality of care that an ICU setting admission into the ICU. Information on ventilator Revised 24 November 2014 implies, mortality remains high. In the USA, Accepted 25 November 2014 settings, clinical management and treatment were collected daily for up to 28 days or until the patient studies show that approximately 30% of all was discharged from the unit. Vital status was patients requiring mechanical ventilation die 2 on September 30, 2021 by guest. Protected copyright. assessed at 90 days post enrolment. A subset of before ICU discharge. A Finnish study esti- participants who survived until hospital discharge were mated a 1-year mortality rate of 35% for asked to participate in an ancillary study to assess vital patients receiving more than 6 h of continu- status, and physical and mental health at 6, 12, 24 and ous mechanical ventilation.5 60 months after hospitalisation, Primary outcomes In contrast, less is known in resource include 90-day mortality, time on mechanical limited settings about clinical practices and ventilation, hospital and ICU lengths of stay, and mechanical ventilation strategies used in crit- prevalence of acute respiratory distress syndrome. In ically ill patients.6 Moreover, the burden of subsequent analyses, we aim to identify interventions and standardised care strategies that can be tailored to critical illness in low and middle income resource-limited settings and that result in improved countries (LMICs) is higher than generally patient-centred outcomes and lower costs. perceived and it is expected to increase with 67 et al8 Ethics and dissemination: We obtained ethics an aging population. Esteban ana- For numbered affiliations see approval from each of the four participating hospitals lysed data from 361 ICUs in 20 countries end of article. in Lima, Peru, and at the Johns Hopkins School of across the Americas and Europe, and showed Medicine, Baltimore, USA. Results will be disseminated a statistically significant mortality difference as several separate publications in different Correspondence to between the USA, European and Latin Dr William Checkley; international journals. American ICUs for all patients receiving [email protected] mechanical ventilation within a 1-month Denney JA, et al. BMJ Open 2015;5:e005803. doi:10.1136/bmjopen-2014-005803 1 Open Access BMJ Open: first published as 10.1136/bmjopen-2014-005803 on 16 January 2015. Downloaded from period, that is, 27% vs 31% vs 34%, respectively. Their stay, mechanical ventilation strategies and selected analysis demonstrates that disparities in mortality rates in aspects of clinical management of critically ill patients the ICUs of varying geographical and socioeconomic requiring at least 24 h of invasive mechanical ventilation status do exist, but did not address what factors may be in five ICUs in Lima, Peru, and in one ICU in the USA contributing to these differences.8 Furthermore, the (figure 1). We further sought to characterise the propor- results from Latin America aggregate data from coun- tion of patients admitted to the ICU with acute respira- tries with varying income levels, which may mask higher tory distress syndrome (ARDS); proportion of patients mortality rates in poorer settings. who developed ARDS while in the ICU; and vital status, ICUs with fewer resources and greater economic lim- physical and mental health at 6, 12, 24 and 60 months itations may have essential differences in delivery of crit- after hospitalisation in a subset of participants. ical care with resulting variations in patient-centred outcomes. These disparities and their effect are not well Outcomes understood.6910Implementation of proven ICU proto- 9 Primary outcomes for this study are 90-day mortality, cols can reduce mortality and costs. Process-driven time on mechanical ventilation, ICU and hospital interventions, such as standardised protocols of care, lengths of stay, and prevalence of ARDS. Additional out- could potentially play a large role in minimising costs comes include vital status at 6, 12, 24 and 60 months for while improving patient outcomes which could be espe- 69 survivors of hospital discharge among participants in cially advantageous in resource-limited settings. Our Peruvian ICUs. A subset of participants will be asked to study focuses on critically ill patients receiving mechan- undergo a follow-up evaluation at 6 months after the fi ical ventilation in LMICs with signi cant resource limita- date of ICU admission to assess the long-term physical tions. Our goal is to better understand best practices in and emotional impact of their hospital stay. resource-limited settings and identify potential changes that could drive significant improvements in outcomes. Study design We present the design of a prospective, longitudinal ‘ ’ cohort of mechanically ventilated patients in Lima, Peru, The INTENSIVOS ( critical in Spanish) cohort is a pro- in five ICUs of public hospitals in Peru and one ICU in spective, observational study. Enrolment began in an academic medical centre in the USA. The study was December 2010 and ended in October 2013. Vital status designed to characterise aetiologies and treatment deci- follow-up and evaluation of physical and mental health sions most frequently seen in mechanically ventilated in a subset of survivors will continue through October patients and their relation to patient-centred outcomes, 2018. This manuscript was written concurrently with the such as 90-day mortality, time on mechanical ventilation, implementation of the protocol and start of this study. and the ICU and hospital lengths of stay. With this infor- At enrolment, we obtained demographic, chronic mation, we aim to identify best practices and standardised disease and acute physiological data for all patients http://bmjopen.bmj.com/ care strategies that can be tailored to resource-limited set- meeting the eligibility criteria. They were followed daily tings and applied in the future in the ICUs to improve to monitor vital status, clinical and ventilator manage- patient-centred outcomes and lower costs. ment, acute physiology and use of sedation during their ICU stay for up to 28 days in the ICU, until ICU dis- charge or death. Patients successfully discharged from METHODS the ICU were followed for vital status during their Study objectives inpatient hospital stay. All patients were contacted We sought to characterise 90-day mortality, time spent at 90 days after enrolment to assess their vital status. on September 30, 2021 by guest. Protected copyright. on mechanical ventilation, ICU and hospital lengths of A subset of participants who survived until hospital Figure 1 Flowchart of participating intensive care units (ICU). 2 Denney JA, et al. BMJ Open 2015;5:e005803. doi:10.1136/bmjopen-2014-005803 Open Access BMJ Open: first published as 10.1136/bmjopen-2014-005803 on 16 January 2015.
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